Device Recall Fresenius 2008Khome Hemodialysis Machine with bibag System

Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042-061 1K0S172179-199 1K0S172200-205 1K0S172263-266 2K0S174112-149 2K0S174228-246 2K0S175602-628 2K0S179477-501 2K0S180512 2K0S180513 2K0S180516-533 2K0S180542 2K0S180543 2K0S180546 2K0S180628 2K0S180629 2K0S181311-332 2K0S181338-340 2K0S181343-347 2K0S181705-719 3K0S182625-659 3K0S183305-324 3K0S183906-920 3K0S183971-980 3K0S184849-912 3K0S185281-284 3K0S185307-311 3K0S185716-745 3K0S185974-989 3K0S185991-998 3K0S186031-045 3K0S186933-962 3K0S186989-7002 4K0S190280 4K0S190306- 4K0S190307 4K0S190309 4K0S190313 4K0S190319 4K0S190509-543 4K0S190829-854 4K0S191122-141 4K0S191229-234 4K0S191511-513 4K0S191569-572 4K0S191578- 588 4K0S192226-245 4K0S192512 4K0S192514-517 4K0S192520 4K0S192522-524 4K0S192526 4K0S192528 4K0S192529 4K0S192533 4K0S192536 4K0S192538 4K0S192540 4K0S192729 4K0S192735 4K0S-J232 4K0S-J943-J944 4K0S-J947-J952 4K0S-L720-L723 4K0S-M703-M708 4K0S-N151- N160 4K0S-N842- N850 4K0S-N913 4K0S-P288- P299 4K0S-P980- P982 4K0S-Q634- Q643 4K0S-Q688- Q697 4K0S-R079- R083 4K0S-R106- R115 4K0S-R134-R138 4K0S-S703- S722 5K0S-159D- 168D 5K0S-180C- 185C 5K0S-305C- 312C 5K0S-320C- 321C 5K0S-322B 5K0S-354D- 363D 5K0S-451B 5K0S-453B-457B 5K0S-459B- 470B 5K0S-866B- 869B 5K0S-877D- 886D 5K0S-T139 5K0S-T880- T899 5K0S-U131 5K0S-V190- V204 5K0S-X981- X983 5K0S-X986- X990 5K0S-Y001- Y010 5K0S-Z650- Z669 6K0S-004Q 6K0S-006M 6K0S-006Q- 014Q 6K0S-007M- 11M 6K0S-008R- 015R 6K0S-016M- 027M 6K0S-017R- 019R 6K0S-027Q- 031Q 6K0S-050M- 053M 6K0S-056N- 063N 6K0S-085L 6K0S-092L 6K0S-191E- 195E 6K0S-216E- 220E 6K0S-317L- 327L 6K0S-318H- 327H 6K0S-331H- 340H 6K0S-431N- 432N 6K0S-435N- 438N 6K0S-466G- 474G 6K0S-467K- 373K 6K0S-469J- 475K 6K0S-476G- 485G 6K0S-477J- 493J 6K0S-477K- 492K 6K0S-501F- 517F 6K0S-532F- 534F 6K0S-610L 6K0S-668L- 673L 6K0S-715R- 718R 6K0S-721R 6K0S-722R 6K0S-725R- 732R 6K0S-745N- 758N 6K0S-770R- 783R 6K0S-787R 6K0S-801K- 803K 6K0S-805K- 822K 6K0S-834N 6K0S-835N 6K0S-844G- 852G 6K0S-938Q- 946Q 6K0S-949Q- 955Q 6K0S-957Q 6K0S-958Q 6K0S-974P- 976P 6K0S-981P 6K0S-982G 6K0S-985P- 987P 6K0S-992P- 998P 7K0S100575- 579 7K0S100615- 618 7K0S100621 7K0S100714 7K0S100716 7K0S100718- 720 7K0S100936- 938 7K0S100940 7K0S101630- 634 7K0S102597- 605 7K0S102656 7K0S102657 7K0S102659- 665 7K0S102982- 986 7K0S103047- 051 7K0S103528- 532 7K0S103595- 599 7K0S103780- 784 7K0S103840- 844 7K0S103895- 899 7K0S104956- 960 7K0S105016 7K0S105020- 023 7K0S105075- 078 7K0S105080 7K0S105990- 994 7K0S106053- 056 7K0S106115 7K0S106374- 378 7K0S106397- 400 7K0S106422 7K0S106456 7K0S106458- 460 7K0S106467 7K0S107627- 631 7K0S107745- 754 7K0S107921- 925 7K0S107994- 999 7K0S108010 7K0S108012 7K0S108015 7K0S108079 7K0S108080 7K0S108255- 258 7K0S108312 7K0S108327- 330 7K0S108372- 376 7K0S108482- 486 7K0S109370- 374 7K0S109397- 401 7K0S109462- 466 7K0S109902- 906 7K0S110118- 121 7K0S110123 7K0S110136- 138 7K0S110141 7K0S110142 7K0S110412 7K0S110416- 418 7K0S110422 7K0S110427 7K0S110428 7K0S110431 7K0S110433 7K0S110434 7K0S110456 7K0S110460- 463 7K0S110484 7K0S110486 7K0S110487 7K0S110489 7K0S110492 7K0S110513 7K0S110514 7K0S110517 7K0S110518 7K0S110521 7K0S110540 7K0S110542 7K0S110543 7K0S110705 7K0S110706 7K0S110710 7K0S110711 7K0S110713 7K0S110715 7K0S110718 7K0S110732 7K0S110733 7K0S110735 7K0S110737 7K0S110739 7K0S110743 7K0S110750 7K0S110769- 771 8K0S117578- 582 8K0S125841 8K0S125842 8K0S125844- 850 8K0S125865 8K0S128089- 120 8K0S131366-399 8K0S131400- 405 8K0S131412- 416 8K0S131420- 447 9K0S134408 9K0S134500

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.

2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX || The Fresenius 2008K is indicated for acute and chronic dialysis therapy.